Comparison of Lidocaine-Prilocaine Combination and Vapocoolant for IV Cannulation Pain in the ED

NCT ID: NCT04473820

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-16

Study Completion Date

2024-05-31

Brief Summary

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Hypothesis: Lidocaine-Prilocaine Combination is as effective as Vapocoolant in treating IV cannulation pain in the emergency department.

Detailed Description

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Lidocain-Prilocaine combination cream is two amide-type local anesthetics used for topical skin anesthesia. Vapocoolant spray is also another method for providing appropriate analgesia through crayoanesthetic mechanisms. Although there are some contraindications and adverse effects, these are widely used in the Emergency Department (ED) for IV cannulation pain.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vapocoolant spray

Patients in this arm will receive vapocoolant spray before IV cannulation.

Group Type ACTIVE_COMPARATOR

Vapocoolant spray

Intervention Type DRUG

The spray will be applied continuously from 25 cm distance for less than 5 seconds to the cannulation site.

Lidocaine-Prilocaine cream

Patients in this arm will receive Lidocaine-Prilocaine cream before IV cannulation.

Group Type ACTIVE_COMPARATOR

Lidocaine-Prilocaine cream

Intervention Type DRUG

A finger tip (0.5 gr) of the cream will be applied in 4 square cm at cannulation site and will be covered with closed dressing for 45 minutes.

Interventions

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Vapocoolant spray

The spray will be applied continuously from 25 cm distance for less than 5 seconds to the cannulation site.

Intervention Type DRUG

Lidocaine-Prilocaine cream

A finger tip (0.5 gr) of the cream will be applied in 4 square cm at cannulation site and will be covered with closed dressing for 45 minutes.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Low acute patients who are waiting for the admission to the ED and require IV cannulation

Exclusion Criteria

* Altered mental status
* Uncooperative patients
* Unable to communicate
* Known history of hypersensitivity reaction to cold or amid analgesics
* Analgesic usage in previous 6 hours
* No consent
* Emergent condition
* Pregnancy and lactation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hadi Mirfazaelian

Assistant Professor of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IKCH

Tehran, , Iran

Site Status

Countries

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Iran

References

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Akhgar A, Mazidabadi Farahani A, Akbari H, Sedaghat M, Jalili M, Mirfazaelian H. Comparison of the effects of vapocoolant spray and topical anaesthetic cream (lidocaine-prilocaine) on pain of intravenous cannulation: a randomised controlled trial. Emerg Med J. 2025 May 22;42(6):373-377. doi: 10.1136/emermed-2024-214479.

Reference Type DERIVED
PMID: 40118519 (View on PubMed)

Other Identifiers

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9111215292

Identifier Type: -

Identifier Source: org_study_id

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